MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number AUL0T0

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

The used device was returned loose inside the opened carton.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to mid-nozzle.The lens was not returned.The nozzle tip upper right side has an area that was slightly bent at the flexible exit.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause cannot be determined for the reported complaint.The used device has a small area at the flexible tip exit that was bent.No other device damage was observed.A review of the product manufacturing records indicated that the product met release criteria.Procedures and processes exist within the manufacturing environment that focus on protection of the nozzle tip.The blister tray design which houses the final inspected product also helps to ensure the finished product is held securely and sealed in a protected position until ready for customer use.Information in the file indicated that the lens was implanted.It is unknown if a plunger over or underride may have occurred, which might have caused the flexible tip to become damaged as the lens was advanced out of the device.The plunger was retracted upon return.The position of the plunger in relation to the lens during advancement cannot be determined.The ifu (instruction for use) instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a negative outcome, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during a cataract extraction with intraocular lens (iol) implant procedure, the tip of preloaded device was found to be deformed after implanting.The iol was implanted without any problems and there was no effect on the patient.The surgery was completed without product replacement.Additional information has been requested.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15457782
• MDR Text Key: 306172302
• Report Number: 1119421-2022-02011
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AUL0T0
• Device Lot Number: 15308630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1